osteoporosis 2016 | the scoop study – do we now have a rationale to screen for osteoporosis? lee...

National Osteoporosis Conference 7th November 2016

The SCOOP study – do we now have a rationale to screen for osteoporosis ?

E LenaghanC CooperS ClarkeR FordhamN GittoesI HarveyN HarveyR Holland

A HoweJA KanisT MarshallTW O’NeillT PetersD TorgersonE McCloskey& the SCOOP study team

A pragmatic randomised controlled trial of the effectiveness and cost effectiveness of screening older women for the prevention of fractures – the SCOOP study.

Is a community based screening programme effective and cost-effective in reducing fractures in older women in the UK?

Cost of Osteoporosis in the UK :- 536 000 new fragility fractures in 2010 - 79 000 hip fractures- Around £3.5 billion each year and rising.

Currently no community based systematic screening in the UK.

Would it be beneficial?

Participants :

(i) Female(ii) Aged 70 to 85(iii) Not on prescription anti-osteoporosis medication(iv) Not deemed inappropriate for research study

Identified from primary care.

Seven geographical regions of the UK.

First randomisation April 2008.

Screening :

(1) FRAX questionnaire by post- 10 year probability of hip fracture

(2) DXA scans in those above risk threshold

(3) FRAX probability re-calculated with BMD- using femoral neck T-score

(4) GPs informed of those at high risk- previous UK thresholds (2004)

Outcomes :

Primary :

i) Proportion of individuals experiencing an osteoporosis-related fracture.

Secondary :

ii) Hip fracturesiii) Mortalityiv) Anxiety (State-Trait Anxiety Inventory)

Five-year follow-up period.

Participant Flow

Women 70–85 yrs from 100 primary care practices

(n = 52,033)

Eligible subjects (n = 38,031)

Consenting participants (n = 13,029)

Randomisation (n = 12,495)

SCREENING n = 6,233

CONTROL n = 6,250

Post-Randomisation Exclusions (n=12)

Randomised (N = 12 483)

Responding Non-Consenters

Has a degree? Yes 2536 (20.3%) 1080 ( 9.9%)Social Class I

IIIIINIIIMIVV

1256 (10.2%)3698 (30.1%)2109 (17.2%)3249 (26.5%)1471 (12.0%) 494 ( 4.0%)

570 ( 5.8%)2206 (22.4%)1651 (16.8%)3196 (32.5%)1476 (15.0%) 739 ( 7.5%)

Fallen in past year? Yes 3445 (27.6%) 2186 (19.9%)Broken bone since 50?

Yes 2863 (22.9%) 1859 (17.0%)

Parents broken hip? Yes 1162 ( 9.3%) 536 ( 5.3%)Smoker? Yes 581 ( 4.7%) 826 ( 7.4%)Moderate Drinker? Yes 444 ( 3.6%) 383 ( 3.4%) Age Mean (SD) 75.4 (4.15) 76.8 (5.84)BMI Mean (SD) 26.6 (4.73) 26.1 (4.90)

Baseline Variables - Randomised versus Responding Non-Consenters

Intervention(N=6233)

Control(N=6250)

Fallen in past year? Yes 1744 (28.0%) 1700 (27.2%)Broken bone since 50? Yes 1399 (22.4%) 1463 (23.4%)Parents broken hip? Yes 585 ( 9.4%) 577 ( 9.2%)Smoker? Yes 290 ( 4.7%) 290 ( 4.6%)Moderate Drinker? Yes 219 ( 3.5%) 225 ( 3.6%)Glucocorticoid Use? Yes 316 ( 5.1%) 312 ( 5.0%)Rheumatoid Arthritis? Yes 426 ( 6.8%) 410 ( 6.6%)Secondary Causes of OP?

Yes 1483 (23.8%) 1408 (22.5%)

Age (at response) Mean (SD) 75.4 (4.16) 75.5 (4.14)BMI Mean (SD) 26.7 (4.71) 26.7 (4.75)FRAX 10 year HIP Probability

Mean (SD) 8.5% (7.4%) 8.5% (7.3%)

FRAX 10 year Major OP Probability

Mean (SD) 19.3% (8.9%) 19.3% (8.8%)

Baseline FRAX Variables - Intervention versus Control

SCREENING participants

n = 6,233

TO DXA

n = 3,064 (49%)

LOW RISK subjects

n = 3,171 (51%)

HIGH RISK subjects

n = 898

LOW RISK subjects

n = 1,917

RISK not Calculated

n = 247

HIGH RISK LOW RISK NOT CALCULATED

n = 898 14% n = 5,088 82% n = 247 4%

Screening Figures

1 2 3 4 5

15.3

13.813.3 13.4

13.9

4.2

6.6

8.1

9.310.1

Percentage of participants with prescription anti-os-teoporosis medication

Screening Control

Year of follow-up

%

Medication Figures

Results

Anxiety (STAI)

0 6 12 24 36 48 600

2

4

6

8

10

12

14

Screening - LOW RISKScreening - HIGH RISKControl

Repeated Measures Analysis

GroupGroup*Time

p=0.515p=0.942

1

12.9 13.6

Osteoporotic-related Fractures%

Hazard Ratio : 0.93 95% CI : 0.85 to 1.03 p=0.199

Results

1

2.63.5

Hip Fractures%


Results

1

8.8 8.4

5-year Mortality%


Results

Discussion Points

Is there a selection bias ?(8.6% mortality vs expected 19.0%)

Why hips and not all fractures ?

28% reduction in hip fractures ?

Conclusions from SCOOP :

1) A community based UK screening programme is feasible, generally well received.

2) No evidence that the overall rate of fractures or mortality could be significantly reduced.

3) Evidence that hip fractures could be reduced.

osteoporosis 2016 | the scoop study – do we now have a rationale to screen for osteoporosis? lee...

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